In 1965, a researcher at G.D. Searle
pharmaceutical company inadvertently discovered the artificial sweetener
aspartame while working on an anti-ulcer medication. It was discovered
that the sweetener was about 150X sweeter than an equal amount of sugar.
Over the next decade, the research staff at the G.D. Searle Company conducted
a series of studies in an effort to get the product approved by the FDA.

Over all this consisted of about 11 different
studies. In 1974 aspartame was approved for use only in dry foods. Its
approval was based on these studies. Yet, even before these studies were
being presented to the FDA, the pharmaceutical giant was under investigation
for improprieties associated with several of its other drugs.

During this investigation, Dr. Adrian
Gross was place in charge of examining these studies and Jerome Bressler
was assigned to examine three of the studies. This investigation included
a through examination of the pathology laboratory used in the tests, interviews
with the scientists and technicians involved and a careful analytic review
of the studies themselves.

In a letter to Senator Howard Metzenbaum,
Dr. Gross discussed many of their findings in this investigation. He pointed
out that at the heart of the regulatory process was the ability of the
FDA to "rely upon the integrity of the basic safety data submitted"
to the FDA. Further, he says, "Our investigation clearly demonstrates
that, in the case of G.D. Searle Company, we have no basis for such reliance
now."

He then pinpoints why he had reached
this conclusion, when he states:

"Through our efforts, we have uncovered
serious deficiencies in Searle's operations and practices which undermine
the basis for reliance on Searle's integrity in conducting high quality
animal research to accurately determine or characterize the toxic potential
of its products."

Dr. Gross expressed his disdain at the
way teratology experiments were conducted. These are critical tests with
any new drug because it determines possible dangers to unborn children
when their mothers are exposed to the product during pregnancy. He found
that technicians responsible for the tests had no formal training in teratology
or toxicology. In fact, they were given some books by the company and trained
themselves for 3 months.

Of most concern was the way the carcinogenicity
tests were conducted. These are tests to see if the product could cause
cancer. According to the law, any product intended as a food product cannot
have demonstrated cancer-causing ability at a dose 100X that commonly consumed.

Even though the tests were poorly conducted
they did demonstrate that aspartame was associated with a dramatic, dose-dependent,
increase in a variety of brain tumors-mainly astrocytomas-the type commonly
seen in humans. This means that the higher the dose of aspartame the more
tumors that were found.

The most appalling findings were by Dr.
Bressler's investigation group. They found that in several instances malignant
tumors were classified as benign and that in others, tumors were removed
from rats and tissue slides and reported as normal.

Dr. John Olney, a neuropathologist and
neuroscientist, pointed out to FDA investigators that aspartame contained
at least two distinct components that could harm the brain-diketopiperizine
and aspartic acid. The former is a suspected carcinogen and the latter
an excitatory amino acid. As a world expert on excitotoxicity, a process
where amino acids such as aspartic acid and glutamic acid causes brain
cells to be excited to death, he understood the real danger to babies and
small children. His laboratory studies had demonstrated that high dose
aspartame could cause the very same brain injury as other excitotoxins.

The 1974 approval was withdrawn and after
the results of these investigations were reviewed privately, aspartame
was given approval once again in 1981. Ironically, it was approved using
the very same studies that resulted in it being banned as too dangerous
for human consumption in 1975.

In 1981, Arthur Hull Hayes was appointed
commissioner of the FDA and in 1983 he approved aspartame for use in beverages.
Three months later her left the FDA and accepted a position as the Senior
Medical Advisor to Searle's PR firm of Burson-Marstellar.

Despite Dr. Olney's, and other neuroscientists
and pathologists', objections, the product was given approval, essentially
for all foods and beverages.

In 1992, Dr. Olney published a study
that suggested that the significant rise in human brain tumors was related
to the widespread use of aspartame, since it began after the approval of
aspartame in foods and beverages. In Searle's original study Dr. Olney
found that there was a 47X increase in brain tumors in the rats exposed
to high dose aspartame. Even Searle's figures showed a 25X increase in
brain tumors. Using existing data Dr. Olney and his co-authors found a
65% increase in brain tumors in humans since aspartame approval. Dr. H.J.
Roberts also reported a similar rise in a rare form of brain cancer associated
with aspartame use.

And a recent study by one of Europe's
most prestigious oncology groups (a million dollar study) found a non-statistically
significant increase in brain tumors in 1800 rats tested using aspartame.
The control animals, which received no aspartame, developed no brain tumors,
whereas the aspartame exposed animals developed 10 malignant gliomas, 1
medulloblastoma and 1 malignant meningioma.

I have had contact with a number of young
women who have developed brain tumors (astrocytomas) following heavy use
of aspartame products. When we combined the experimental studies with the
clinical data it is obvious that aspartame is strongly linked to brain
tumors and most likely lymphomas and leukemias.

Of great concern is the study by Trocho
and his co-workers from the University of Barcelona, which found that aspartame
was absorbed and then broken down into its component parts, including methanol
and the methanol was further broken down into formic acid and formaldehyde.
Using sophisticated radioactive labeling techniques he proved that the
formaldehyde from the aspartame attached itself to the DNA, RNA and proteins
of cells and that it was very difficult to removed. Further, they showed
that the formaldehyde caused breaks in the DNA.

This has major implications in humans,
since DNA damage, as was seen in their study, causes a multitude of cancers
in humans as well as worsening of autoimmune diseases, diabetes and neurodegenerative
diseases such as Alzheimer's dementia, Parkinson's and ALS. It also causes
concern because DNA breaks in the DNA in sperm and ova can cause increased
cancer risk and developmental problems in the offspring of mothers and
fathers consuming aspartame products.

In the Bressler examination of the Searle
tumor study they found that the female animals exposed to aspartame had
a very high incidence of uterine polyps, which were rare in rats not exposed.
In fact, at even moderate doses, there was a 15X increase in uterine polyps.
In addition, they found several ovarian tumors, breast fibroadenomas, several
pituitary adenomas, several lymphomas and pancreatic tumors.

The new million-dollar study by Dr. Morando
Soffritti and co-workers found a dramatic increase in malignant lymphomas
and leukemias in female rats consuming even low doses of aspartame-doses
known to be consumed by millions of children, pregnant women and others.
Their carefully done study concluded that most likely it was the formaldehyde
breakdown product from the aspartame that was causing the cancers, which
confirms what Trocho and co-workers had found earlier. Formaldehyde is
known to be a powerful toxin and carcinogen, even in low concentrations.

Of great concern was the finding by Trocho,
that formaldehyde tends to accumulate in the DNA and is difficult to remove.
This means that drinking even a single diet cola sweetened with aspartame
can eventually produce significant DNA damage to raise one's risk of cancer
and other diseases. Today, over 5000 products contain aspartame. It is
also important to appreciate that we are exposed to a number of toxic and
carcinogenic chemicals, which can add to aspartame's toxicity.

There are sufficient studies on the effect
of aspartame on the developing fetus to draw serious concern about the
safety of this product. For example, it has been shown that aspartame in
the dose accepted as safe by the FDA (50 mg/kg/day) can produce phenylalanine
levels in a large number of women and their babies during pregnancy-large
enough to produce abnormal development of the baby's brain. This is because
phenylalanine interferes with the normal migration and connections of the
developing brain.

In my estimation, pregnant women should
never consume foods containing aspartame at any level, for the reasons
I have discussed. The aspartic acid, phenylalanine and methanol are all
known to produce abnormal development of a baby's brain.

There is also evidence from the studies
done by Dr. Ralph Walton, indicating that depressed people are especially
sensitive to the toxic effects of aspartame and that this is especially
true of those with suicidal tendencies. In a separate study he has shown
that virtually all of the independently conducted studies done on aspartame
safety have found problems with the product, yet not a single study funded
by the makers of aspartame (now Monsanto) reported even minor problems.

This is especially puzzling when you
consider that among all the food-related complained registered by the FDA,
75 to 85% are related to aspartame. This alone should tell us there is
a problem.

There are sufficient independent studies
to show that aspartame is a dangerous product and that it should have never
been given approval. In fact, it was approved using the same shoddy studies
alluded to by Dr. Adrian Gross in his letter to Senator Howard Metzenbaum.